Details for New Drug Application (NDA): 210854
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NDA 210854 describes XOFLUZA, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the XOFLUZA profile page.
The generic ingredient in XOFLUZA is baloxavir marboxil. One supplier is listed for this compound. Additional details are available on the baloxavir marboxil profile page.
The generic ingredient in XOFLUZA is baloxavir marboxil. One supplier is listed for this compound. Additional details are available on the baloxavir marboxil profile page.
Summary for 210854
| Tradename: | XOFLUZA |
| Applicant: | Genentech Inc |
| Ingredient: | baloxavir marboxil |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210854
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 210854
| Mechanism of Action | Chelating Activity Polymerase Acidic Endonuclease Inhibitors |
Suppliers and Packaging for NDA: 210854
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860 | 50242-860-01 | 1 BLISTER PACK in 1 CARTON (50242-860-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| XOFLUZA | baloxavir marboxil | TABLET;ORAL | 210854 | NDA | Genentech, Inc. | 50242-860 | 50242-860-86 | 1 BLISTER PACK in 1 CARTON (50242-860-86) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 24, 2018 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Apr 27, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TREATING INFLUENZA | ||||||||
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